Novartis has received Chinese approval for Vanrafia (atrasentan) to reduce proteinuria in high-risk primary IgA nephropathy (IgAN) patients, marking the first endothelin receptor antagonist clearance for this indication in China. The oral selective endothelin A (ETA) blocker demonstrated 36.1% greater proteinuria reduction versus placebo at 36 weeks in the Phase III ALIGN trial, with benefits emerging as early as six weeks. IgA nephropathy affects approximately four million Chinese patients, with half progressing to kidney failure within two decades without effective intervention.

The approval establishes Vanrafia as a non-immunosuppressive foundation therapy alongside Novartis' complement inhibitor Fabhalta (iptacopan) for rare kidney diseases. China's National Medical Products Administration (NMPA) clearance follows an accelerated approval in the US in April 2025, positioning Novartis as the leader in targeted IgA nephropathy therapies addressing both complement and endothelin pathways. Commercial launch is expected in Q4 2025 through Novartis' established nephrology specialty care network.

According to PharmCube's NextBiopharm® database, the product is also approved in China for proteinuria, and is in Phase III development for diabetic nephropathy (DN). Click here to request a free trial for NextBiopharm®.